Since technological advancements have allowed for more data-driven clinical research, centralized monitoring in clinical trials has become an important approach in off-site and on-site monitoring plans.
Here, we discuss the importance of centralized Monitoring in clinical trials for data integrity in clinical trials.
1. Centralized Monitoring in Clinical Trials Effect on Cost Efficiency
Clinical process validation and monitoring requires a massive number of financial resources and participants. However, centralized monitoring can help reduce the required resources. Since on-site monitoring usually accounts for 25-30% of overall clinical trial costs, using centralized monitoring can make a substantial impact by lowering the need for costly and frequent on-site visits and enhancing the fewer essential visits.
Thanks to centralized monitoring, these visits can be less expensive and less frequent as they’re paired with reliable data. But centralized monitoring may still need a software investment depending on the sites and sponsor, though certain capabilities for centralized monitoring may already exist. Still, it can affect spending for the overall clinical trial, including the resulting treatment costs.
2. Speed
With centralized monitoring, identifying the highest risk sites rapidly becomes possible, allowing prioritization by targeting sites with the most important issues. It also allows site staff to adapt to these issues with confidence through planned mitigation methods that are established in centralized monitoring implementation. Thus, larger problems are prevented through focused resources and communication. This doesn’t just keep the clinical trial results valid but safeguards the trial subjects.
3. High quality
The implementation of centralized monitoring is one of the most effective ways of ensuring a high level of data quality and overall quality of the clinical trial. According to the FDA, centralized monitoring can identify almost 90% of on-site monitoring findings. Moreover, it improves patient safety with data tracking to understand which variables impact the clinical trial’s efficacy, thus improving trial integrity among a number of sites.
With centralized monitoring, abnormalities can be unearthed during the preliminary stages, allowing for corrections and adjustments. This results in higher quality regulatory submissions and decreases time to marketing approval.
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